Adolescent Idiopathic ScoliosisPOMNCT01661998
Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Setting Scoliosis Straight Foundation at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 273 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Who may be able to join
- Patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria:
- Patient age < 21 years
- Male or female
- Diagnosis of Adolescent Idiopathic Scoliosis
- Any Lenke Classification type
- Underwent surgical correction of the spinal deformity with a fusion
- Are due for their 10 year post-operative visit
Who cannot join
- Patients will be excluded from study inclusion if they meet the following exclusion criteria:
- Neuromuscular co-morbidity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Scoliosis Associates & NYU Hospital for Joint Diseases
New York, New York, 10017
Shriners Hospital for Children
Philadelphia, Pennsylvania, 19140
Rady Children's Hospital
San Diego, California, 92123
About this study
Official title: Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
Read the detailed description
The motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the following specific clinical questions:
- Further elucidate the motion behavior of the distal unfused spinal segments, specifically:
- Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)?
- Can predictive factors be identified with post-operative altered motion?
- Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae.
- Determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6 patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).
- Determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (Health Related Quality of Life Outcome Tools) to motion in the distal unfused segments.
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Spinal Deformity, Treatment Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Harms Study Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.
Data collected at patients 10 years visit.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJun 2008
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Setting Scoliosis Straight Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine
- Responsible party
- Sponsor
- Investigators
- Peter Newton, MD, Study director, Rady Children's Hospital San Deigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661998
- Sponsor's protocol ID
- 2009HSGF05
- Acronym
- POM
- Status last verified
- Apr 2019
- First submitted
- 10 Jul 2012
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT01661998
- Acronym / sponsor ID
- POM / 2009HSGF05
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Spinal Deformity, Treatment Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Setting Scoliosis Straight FoundationUniversity, hospital or other
- Collaborators
- DePuy Spine
- Study start
- Jun 2008
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
Detailed description
The motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the following specific clinical questions:
- Further elucidate the motion behavior of the distal unfused spinal segments, specifically:
- Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)?
- Can predictive factors be identified with post-operative altered motion?
- Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae.
- Determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6 patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).
- Determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (Health Related Quality of Life Outcome Tools) to motion in the distal unfused segments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harms Study Group | – | – |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who present to the investigator's clinic, who meet the inclusion criteria will be offered enrollment in the study
Key inclusion criteria (7 listed)
- Patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria:
Key exclusion criteria (2 listed)
- Patients will be excluded from study inclusion if they meet the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward.
Time frame: 10 years
Data collected at patients 10 years visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Setting Scoliosis Straight Website - highlighting the research of the Harms Study GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Newton, MD study director
Rady Children's Hospital San Deigo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Setting Scoliosis Straight Foundation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis. Range of motion is assessed by side-bending to the left and to the right as well as bending forward. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.